The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

Thyroid Diseases Clinical Trial

Official title:

A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158961
• Other study ID #: UW 17-144
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong. The following are the procedure of the study: 1. Recruit patients from the clinic. 2. Patients will receive treatment within 3 months 3. Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month. 4. Patients will be monitoring by the same team after the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• have a cyst, nodule or a goiter which has been shown to be benign on fine needle aspiration cytology,
• need to undergo a unilateral thyroid resection,
• have a nodule size no larger than 4cm in largest diameter,
• willing to undergo this new approach rather than the traditional open approach.

Exclusion Criteria:

• unfit for surgery,
• has had previous surgery or radiation at the neck,
• unable to tolerate a general anesthesia,
• wearing dental braces,
• absence of vocal cord mobility at laryngoscopy.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• Transoral endoscopic thyroidectomy vestibular approach
TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (13)

Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1. — View Citation

Benhidjeb T, Wilhelm T, Harlaar J, Kleinrensink GJ, Schneider TA, Stark M. Natural orifice surgery on thyroid gland: totally transoral video-assisted thyroidectomy (TOVAT): report of first experimental results of a new surgical method. Surg Endosc. 2009 May;23(5):1119-20. doi: 10.1007/s00464-009-0347-0. Epub 2009 Mar 5. — View Citation

Bergenfelz A, Jansson S, Kristoffersson A, Mårtensson H, Reihnér E, Wallin G, Lausen I. Complications to thyroid surgery: results as reported in a database from a multicenter audit comprising 3,660 patients. Langenbecks Arch Surg. 2008 Sep;393(5):667-73. doi: 10.1007/s00423-008-0366-7. Epub 2008 Jul 17. — View Citation

Clark MP, Qayed ES, Kooby DA, Maithel SK, Willingham FF. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;2012:189296. doi: 10.1155/2012/189296. Epub 2012 Jun 6. — View Citation

Erdogan MF, Gursoy A, Erdogan G. Natural course of benign thyroid nodules in a moderately iodine-deficient area. Clin Endocrinol (Oxf). 2006 Dec;65(6):767-71. — View Citation

Hegedüs L, Bonnema SJ, Bennedbaek FN. Management of simple nodular goiter: current status and future perspectives. Endocr Rev. 2003 Feb;24(1):102-32. Review. — View Citation

Inabnet WB 3rd, Suh H, Fernandez-Ranvier G. Transoral endoscopic thyroidectomy vestibular approach with intraoperative nerve monitoring. Surg Endosc. 2017 Jul;31(7):3030. doi: 10.1007/s00464-016-5322-y. Epub 2016 Nov 10. — View Citation

Lang BH. Minimally invasive thyroid and parathyroid operations: surgical techniques and pearls. Adv Surg. 2010;44:185-98. Review. — View Citation

Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33. — View Citation

Udelsman R, Anuwong A, Oprea AD, Rhodes A, Prasad M, Sansone M, Brooks C, Donovan PI, Jannitto C, Carling T. Trans-oral Vestibular Endocrine Surgery: A New Technique in the United States. Ann Surg. 2016 Dec;264(6):e13-e16. — View Citation

Wilhelm T, Metzig A. Endoscopic minimally invasive thyroidectomy (eMIT): a prospective proof-of-concept study in humans. World J Surg. 2011 Mar;35(3):543-51. doi: 10.1007/s00268-010-0846-0. — View Citation

Wilhelm T, Metzig A. Video. Endoscopic minimally invasive thyroidectomy: first clinical experience. Surg Endosc. 2010 Jul;24(7):1757-8. doi: 10.1007/s00464-009-0820-9. Epub 2009 Dec 25. — View Citation

Witzel K, von Rahden BH, Kaminski C, Stein HJ. Transoral access for endoscopic thyroid resection. Surg Endosc. 2008 Aug;22(8):1871-5. Epub 2007 Dec 28. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The complication rate after TOETVA in 12 months	To record any complication of surgery in every post-operation visit after 12 months. The record will be used for the calculation of complication rate.	12 months
Secondary	The open conversion rate of TOETVA	To record any cases which need to apply open surgery necessary during the procedure of TOETVA	12 months
Secondary	The wound infection rate after TOETVA	To record the situation of wound infection after surgery	12 months
Secondary	The hematoma rate after TOETVA	To record the situation of hematoma after surgery	12 months
Secondary	The vocal cord palsy rate after TOETVA	To calculate the vocal cord situation after surgery within 12 months	12 months
Secondary	The hypoparathyroidism rate after TOETVA	To record the thyroid function from blood test in 12 months after surgery and calculate the rate of hypo-parathyroid function	12 months
Secondary	The pain score of patient after TOETVA	The pain scoring with 0-10 to assess the pain level of having TOETVA	12 months
Secondary	The satisfaction of patients after having TOETVA in 12 months	The satisfaction in 0-10 scoring after the surgery	12 months